A Study of Pemetrexed and Cyclophosphamide Given Every 21 Days in Advanced Breast Cancer Patients
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00190671
First received: September 12, 2005
Last updated: November 17, 2009
Last verified: November 2009
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Purpose
This is the phase 2 portion of a phase 1/2 trial, testing the use of pemetrexed and cyclophosphamide in combination for the treatment of advanced breast cancer. A single arm Phase 1 dose finding (establish maximum tolerated dose) study precedes the randomized phase 2 portion.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: pemetrexed Drug: cyclophosphamide |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1/2 Dose-Escalating Study of ALIMTA and Cyclophosphamide Administered Every 21 Days in Patients With Locally Advanced or Metastatic Breast Cancer |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Best Tumor Response [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to Progressive Disease [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
- Progression Free Survival [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
- Pharmacokinetics - Maximum Observed Drug Concentration (Cmax) [ Time Frame: cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion) ] [ Designated as safety issue: No ]
- Pharmacokinetics - Area Under the Curve (AUC) [ Time Frame: cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion) ] [ Designated as safety issue: No ]
- Pharmacokinetics - Clearance (CL) [ Time Frame: cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion) ] [ Designated as safety issue: No ]
- Pharmacokinetics - Volume of Distribution [ Time Frame: cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion) ] [ Designated as safety issue: No ]
- Pharmacokinetics - Half-Life (t½) [ Time Frame: cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion) ] [ Designated as safety issue: No ]
| Enrollment: | 103 |
| Study Start Date: | June 2005 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Pemetrexed 600 mg/m2 |
Drug: pemetrexed
Pemetrexed: 600 mg/m2, intravenous (IV), every 21 days x 8 cycles
Other Names:
Drug: cyclophosphamide
600 mg/m2, intravenous (IV), every 21 days x 8 cycles
|
| Experimental: Pemetrexed 1800 mg/m2 |
Drug: cyclophosphamide
600 mg/m2, intravenous (IV), every 21 days x 8 cycles
Drug: pemetrexed
1800 mg/m2, intravenous (IV), every 21 days x 8 cycles
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- You must be female and at least 18 years old.
- You must have been diagnosed with breast cancer.
- Your pre-study lab tests are within study requirements.
- You must be willing to take folic acid and vitamin B12.
Exclusion Criteria:
- You are pregnant or breastfeeding.
- You have another illness that your doctor thinks would make you unable to participate.
- You are currently taking aspirin or aspirin-like medicine and are unable to stop for a few days during each cycle of therapy.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190671
Locations
| Austria | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph | |
| Salzburg, Austria, 5020 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph | |
| Wels, Austria, 4600 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph | |
| Wien, Austria, A-1100 | |
| Czech Republic | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph | |
| Brno, Czech Republic, 625 00 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph | |
| Nova Ves Pod Plesi, Czech Republic, 26204 | |
| Hungary | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph | |
| Budapest, Hungary, 1122 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph | |
| Szeged, Hungary, 6720 | |
| Poland | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph | |
| Gdansk, Poland, 80-210 | |
| Romania | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph | |
| Bucharest, Romania, 022328 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph | |
| Cluj-Napoca, Romania, 3400 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph | |
| Iasi, Romania, 6600 | |
| Russian Federation | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph | |
| Moscow, Russian Federation, 129128 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal ph | |
| Saint Petersburg, Russian Federation, 197022 | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9am- 5pm Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
More Information
No publications provided
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00190671 History of Changes |
| Other Study ID Numbers: | 4029, H3E-MC-JMDV |
| Study First Received: | September 12, 2005 |
| Results First Received: | March 17, 2009 |
| Last Updated: | November 17, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Eli Lilly and Company:
|
Advanced Breast Cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Cyclophosphamide Pemetrexed Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Enzyme Inhibitors Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on May 22, 2013